Gamanea

Medicinal product

(Invented) name

Gamanea

Active substance (s)

Gabapentinas

Strength

300 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

Yes

ATC code (s)

N02BF01, Gabapentin

Marketing authorisation holder

G.L. Pharma GmbH, Austrija

Date of authorisation

2025-07-18

Date of renewal

Documents

5822-23-24_pakuotes lapelis_2025-07-18.docx

5822_5823_5824_Gamanea.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

CZ/H/1426/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Gabapentinas	300 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
118098	104205	1104205	lizdinė plokštelė	N50		Receptinis	LT/1/25/5823/001	Netiekiama	-	-	No	-	-
118099	104206	1104206	lizdinė plokštelė	N100		Receptinis	LT/1/25/5823/002	Netiekiama	-	-	No	-	-
118100	104207	1104207	lizdinė plokštelė	N200		Receptinis	LT/1/25/5823/003	Netiekiama	-	-	No	-	-
118101	104208	1104208	buteliukas	N30		Receptinis	LT/1/25/5823/004	Netiekiama	-	-	No	-	-
118102	104209	1104209	buteliukas	N90		Receptinis	LT/1/25/5823/005	Netiekiama	-	-	No	-	-
118103	104210	1104210	buteliukas	N100		Receptinis	LT/1/25/5823/006	Netiekiama	-	-	No	-	-
118104	104211	1104211	buteliukas	N500		Receptinis	LT/1/25/5823/007	Netiekiama	-	-	No	-	-
118105	104212	1104212	buteliukas	N1000		Receptinis	LT/1/25/5823/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-07-18	Registruotas